Over-the-counter drug · ANDA
Aleve Arthritis Pain Gel (Diclofenac sodium) NDC 0280-0039
Diclofenac sodium 1 mg/g · Gel · Topical · Bayer HealthCare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-0039-01 | 0028000390100280003901 | 1 TUBE in 1 CARTON (0280-0039-01) / 100 g in 1 TUBEMarketed from Jun 1, 2021 | |
| 0280-0039-02 | 0028000390200280003902 | 1 TUBE in 1 CARTON (0280-0039-02) / 50 g in 1 TUBEMarketed from Jun 1, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Aleve Arthritis Pain Gel
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bayer HealthCare LLCNDC labeler code 0280
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211253
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 0280-0039_452615d3-7d62-4fa6-e063-6394a90a5dfdSPL ID 452615d3-7d62-4fa6-e063-6394a90a5dfdSPL set ID bad675d1-1204-0136-e053-2995a90a994eRxCUI 855633, 2550740UNII QTG126297QUPC 0025866593619
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400280003901followed by a unit qualifier and the quantityPackage 00280-0039-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses for temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Excerpt only. Read the full label for complete information.
About NDC 0280-0039
- What is NDC 0280-0039?
- 0280-0039 is the product NDC for Aleve Arthritis Pain Gel (diclofenac sodium), Diclofenac sodium 1 mg/g gel, listed with the FDA by Bayer HealthCare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aleve Arthritis Pain Gel (Diclofenac Sodium).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Bayer HealthCare LLC, NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aleve Arthritis Pain Gel?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 211253
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Arthritis Pain Reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-517 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | H E B | 37808-087 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | HyVee Inc | 42507-150 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-471 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-878 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | H E B | 59640-198 |
| Arthritis Pain Relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-3003 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-5123 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Meijer Distribution Inc | 41250-674 |
| Arthritis Pain Relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Meijer, Inc. | 79481-0499 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0573 |
| basic care arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Amazon.com Services LLC | 72288-870 |
| berkley and jensen arthritis paindiclofenac sodium | — | Kit | BJWC | 68391-205 |
| CareOne arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | American Sales Company | 41520-788 |
| DG health arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-424 |
| Dg Health Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-926 |
| Diclofenacdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | YYBA CORP | 73581-410 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Rite Aid Corporation | 11822-0870 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-953 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3456 |
Showing 20 of 39.